Once-daily versus twice-daily ramipril for kidney health in CKD patients with reduced ejection fraction heart failure
Comparative Effects of Single Versus Twice-Daily Ramipril Dosing on Renal Function in Patients With Chronic Kidney Disease and Heart Failure With Reduced Ejection Fraction: Evaluation of Plasma Renin Activity, Malondialdehyde, Interleukin-6, Albuminuria, and Cystatin C
This trial tests whether taking ramipril once a day or split into twice-daily doses better protects kidney function in adults who have chronic kidney disease and heart failure with reduced ejection fraction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitas Sebelas Maret Academic / other |
| Locations | 1 site (Kartasura, Central Java) |
| Trial ID | NCT07259512 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, parallel-assignment trial compares ramipril 10 mg once daily with ramipril 5 mg twice daily in adults with CKD stage 3–5 (not on dialysis) and heart failure with reduced ejection fraction (EF < 40%). Participants receive assigned dosing for 30 days while researchers measure plasma renin activity, malondialdehyde, interleukin-6, albuminuria, and cystatin C to track renal and inflammatory responses. The trial excludes patients on dialysis, those taking ARBs or sacubitril-valsartan, and patients with ACE inhibitor intolerance or angioedema history. The single-site study is conducted at UNS Hospital in Kartasura, Central Java.
Who should consider this trial
Good fit: Adults over 18 with chronic kidney disease stage 3–5 (not on dialysis) and heart failure with reduced ejection fraction (EF < 40%) who can stop ARBs/sacubitril-valsartan and have no ACE inhibitor contraindications are ideal candidates.
Not a fit: Patients on hemodialysis, those with prior ACE inhibitor intolerance or angioedema, pregnant people, or those with refractory hyperkalemia or symptomatic hypotension are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the trial could identify a ramipril dosing schedule that better preserves kidney function and lowers markers of inflammation and oxidative stress in CKD patients with reduced ejection fraction heart failure.
How similar studies have performed: ACE inhibitors like ramipril are proven to benefit CKD and HFrEF broadly, but direct randomized comparisons of once-daily versus twice-daily ramipril for renal biomarkers are limited, so this addresses a relatively novel practical question.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female or Male with age \>18 years old * Patients with a diagnosis of CKD stage 3-5 non-dialysis with low ejection fraction heart failure (ejection fraction \< 40%) Exclusion Criteria: * Receiving hemodialysis therapy * History of intolerance to ACE inhibitors * Refractory hyperkalemia * Pregnancy * History of angioedema to ACE inhibitors * Receiving sacubitril-valsartan therapy * Receiving ARB therapy * Hypotension with blood pressure \<90/60, or patients in shock.
Where this trial is running
Kartasura, Central Java
- UNS Hospital — Kartasura, Central Java, Indonesia (Recruiting)
Study contacts
- Study coordinator: Evi L Wulandari, MD., Internist
- Email: evililiek@staff.uns.ac.id
- Phone: (+62)821-3587-2749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.